Ignite Creation Date:
2024-05-06 @ 6:53 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05814146
Status:
RECRUITING
Last Update Posted:
2024-02-26
First Post:
2023-03-20
Brief Title:
Trial of Variable Dialysate Bicarbonate
Sponsor:
Brigham and Womens Hospital
Organization:
Brigham and Womens Hospital
Study Overview
Official Title:
Randomized Controlled Double-blind Trial of Lower Versus Higher Dialysate Bicarbonate in Hospitalized Maintenance Hemodialysis Patients
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
QTc prolongation and premature ventricular contractions PVCs are common in hemodialysis HD patients and are associated with sudden cardiac death
It is known that higher dialysate bicarbonate is associated with more QTc prolongation during HD sessions
This study aims to assess the effects of lower 30 mEqL versus higher 35 mEqL dialysate bicarbonate in adult maintenance HD patients admitted to the hospital
The investigators will randomly assign subjects to lower versus higher dialysate bicarbonate concentrations during their hospital stay for up to a maximum of six HD sessions or until their hospital discharge
It is known that higher dialysate bicarbonate is associated with more QTc prolongation during HD sessions
This study aims to assess the effects of lower 30 mEqL versus higher 35 mEqL dialysate bicarbonate in adult maintenance HD patients admitted to the hospital
The investigators will randomly assign subjects to lower versus higher dialysate bicarbonate concentrations during their hospital stay for up to a maximum of six HD sessions or until their hospital discharge
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None